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Study Start-Up Manager (Wilmington, DE)

CEDENT

Wilmington, DE
Summary

We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site management, and expertise in ensuring compliance with local and international guidelines, particularly ICH-GCP.

Key Responsibilities
  • Lead and manage start-up activities for clinical studies, ensuring compliance with local and international guidelines (ICH-GCP).
  • Prepare, review, and track site regulatory documentation throughout the study start-up phase.
  • Collaborate with Clinical Research Associates (CRAs) and the local study team to meet start-up milestones.
  • Participate in Local Study Team meetings and report on site performance metrics.
  • Ensure the timely submission of documents to regulatory authorities and maintain the trial master file (eTMF).
Qualifications
  • Minimum 3 years of experience in Clinical Study Start-Up (full-time).
  • At least 1 year of hands-on experience with Veeva Vault.
  • Strong background in informed consent review and negotiation.
  • Bachelor’s degree (higher degree preferred) with knowledge of clinical trial processes (Phases II-IV) and ICH-GCP.
  • Excellent communication, organizational, and project management skills.
  • Strong problem-solving and negotiation abilities.

Department: Direct Clients
This is a full time position

Apply
Vacancy posted more than 2 months ago
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